Device recall
Z-2002-2016: Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets…
FDA device recall · Class II · Datascope Corporation
Key facts
| Recall number (Z-number) | Z-2002-2016 |
|---|---|
| Recall event | 74341 |
| Product | Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing… |
| Product code | DWE |
| Recalling firm | Datascope Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 28, 2017 |
| FEI number | 1000222374 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database